A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/192 (2006.01) A61J 3/07 (2006.01) A61K 9/48 (2006.01)
Patent
CA 2690488
This invention relates to a naproxen formulation suitable for encapsulation into a soft gel dosage unit by increasing the stability, concentration, and bioavailability of naproxen. Fill formulations of the invention may include other active pharmaceutical ingredients and combinations of two or more active pharmaceutical ingredients. This invention also provides for adjusting pH values of fill formulations without additional process steps. A process for increasing the achievable concentration of an active pharmaceutical ingredient relative to fill composition for dosage units is also provided. The process is particularly useful in the preparation of soft gel dosage units of naproxen. The highly concentrated formulation of this invention permits a reduction in the fill volume or dosage unit size, or an increase in concentration of the active pharmaceutical ingredient per dosage form. The invention also relates to a formulation of optimal stability suitable for supporting a fill composition compatible with the soft gel dosage unit.
Armstrong Christina
Draper Peter
Klassen Nancy
Lopez John
Vashishtha Sankalp
Accucaps Industries Limited
Deeth Williams Wall Llp
LandOfFree
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